NCT07321002

PFLotus With the DePolar Mapping System in Patients With Persistent Atrial Fibrillation

Not yet recruiting NA Last updated 6 January 2026

What this trial tests

NA trial testing Ablation with the PFLotus catheter and Depolar system in Persistent Atrial Fibrillation in 35 participants. Not yet recruiting.

Timeline

22 December 2025

Primary endpoint
1 June 2026

31 July 2027

Quick facts

Lead sponsor	The Third People's Hospital of Chengdu
Phase	NA
Status	Not yet recruiting
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	35
Start date	22 December 2025
Primary completion	1 June 2026
Estimated completion	31 July 2027

Drugs / interventions tested

• Ablation with the PFLotus catheter and Depolar system

Conditions studied

• Persistent Atrial Fibrillation — all drugs for Persistent Atrial Fibrillation →

Sponsor

The Third People's Hospital of Chengdu

Who can join

Adults 18 to 75, any sex, with Persistent Atrial Fibrillation. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

This clinical trial aims to evaluate the safety and efficacy of pulmonary vein isolation (PVI), focal, and linear ablation in patients with persistent atrial fibrillation (PersAF) using a novel shape-adaptive pulsed field ablation (PFA) catheter (PFLotus, EnChannel Medical) integrated with a novel mapping system (DePolar, EnChannel Medical).

The primary study objectives are to determine:

* The incidence of serious procedure- or device-related adverse events within 7 days post-procedure (primary safety endpoint).
* The clinical effectiveness of the integrated PFA and mapping system.
* The ability of the novel PFA system to produce durable ablation lesions.

PersAF patients will be treated under general anesthesia using the PFLotus PFA catheter (bipolar, biphasic waveform; 850 V, 60 μs per pulse). Ablation targets, including PVI and other lesions (left atrial posterior wall, mitral isthmus, cavotricuspid isthmus, and superior vena cava), will be accessed under fluoroscopic and DePolar mapping system guidance.

Participants will:

1. Receive PVI, focal, and linear ablation using the PFLotus PFA catheter and DePolar mapping system under general anesthesia;
2. Be monitored for serious procedure- or device-related adverse events during the first 7 days post-procedure;
3. Undergo repeat electrophysiological mapping at 3 months to assess lesion durability;
4. Attend scheduled follow-up visits at 7 days, 30 days, and 3, 6, and 12 months post-ablation. Atrial arrhythmia recurrence will be assessed via 12-lead electrocardiography at each visit and by 24-hour or 7-day Holter monitoring at the 6- and 12-month visits.

Publications & conference data

No peer-reviewed publications indexed yet for this trial.